Powder coated malleable hydrophobic orthodontic device shield

ABSTRACT

An orthodontic protection device that includes: an extruded base material having an uncured, uncross-linked silicone high consistency rubber base where the extruded base material has at least one dry, powdered hydrophilic polymeric substance mechanically or frictionally engaged with and dispersed on a surface of the extruded base material thereby forming a finger force malleable hydrophobic base material composite configured to be applied to a surface of a tooth, a surface of an orthodontic appliance or both a surface of a tooth and a surface of an orthodontic appliance using finger pressure within about eight seconds or less.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority to and the benefit of U.S.Provisional Patent Application Ser. No. 62/555,454 entitled PowderCoated Malleable Hydrophobic Orthodontic Device Shield, which was filedon Sep. 7, 2017. The present application also claims priority to and thebenefit of U.S. Provisional Patent Application Ser. No. 62/555,459entitled Powder Coated Malleable Hydrophobic Orthodontic Device Shield,which was filed on Sep. 7, 2017, the entire contents of which are herebyincorporated by reference.

BACKGROUND

Certain types of finger force malleable compositions, in particularhydrocarbon based orthodontic wax, have been used by orthodonticpatients in an effort to provide relief from pain and irritation due tocontact of the oral mucosa with one or more orthodontic hardware such asbrackets and wires. The most common finger force malleable compositionsare hydrocarbon based wax formulations (often a blend of varioushydrocarbon based waxes and fillers) known as Orthodontic Relief Wax(See 10 in FIG. 1). Another type of finger force malleable compositionfor relief from pain and irritation of orthodontic devices is siliconeun-crosslinked high consistency rubber base (understood by those in theart to consist of a proprietary blend of one more silicones withuntreated and/or treated silica filler), presently commercialized asORTHOSIL™. These materials are extremely hydrophobic and completelynon-adhering to wet (with water) surfaces. Since saliva is approximately99.5% water and coats teeth and orthodontic appliances, often poolingwithin and coating surfaces around orthodontic brackets, orthodonticpatients often find it very difficult to get these hydrocarbon andsilicone based compositions to adhere and stay in place when applied totheir braces. Indeed, the instructions that accompany ORTHOSIL™ state“To use OrthoSil your brackets must be totally dry for the product toadhere properly.” Unfortunately this is difficult to accomplish.

An attempt to solve this problem are ORTHODOTS®, sold by OrVance, LLC.These are silicone based compositions. One version employs apolyvinylpyrrolidone (PVP)/glycerin/water solution/formulation sprayedonto the surface of the silicone composition, followed by prolongedheating to evaporate the water and arrive at a surface coated withhardened adhesive beads that render the device adhesive to wet teeth andbraces. However, the hardened adhesive beads take at least 10 to 15seconds to hydrate and develop adhesion upon pressing onto wet teeth andbraces, and the beads themselves often come loose from the device in thepackage before use, potentially rendering the device non-adhesive to wetteeth and braces or causing even longer force to be applied to thedevice to get them to adhere to the teeth. Another silicone based fingerforce malleable product invented by the present inventor also has thePVP and glycerin, but the solution is mixed throughout the siliconecomposition to yield a homogeneous composite. However, due to thedramatic difference in properties between the hydrophobic silicone andthe hydrophilic PVP and glycerin, the resulting composite is a brightwhite color (See 12 in FIG. 1), an attribute that makes the devicevisually readily obvious to others when worn and thus unsatisfactory toa majority of patients, especially patients worried about personalappearance when wearing the device. Additionally, because the PVP isdistributed throughout the silicone, the surface of the device is stillmajority silicone. The result is the device again takes at least 10 to15 seconds of finger pressure during application to get it tosuccessfully adhere and stay adhered to wet teeth and braces, and thedevice sometimes fails to stay adhered due to competitive adhesion tothe finger pressing it on to the braces.

SUMMARY

An aspect of the present disclosure is generally directed to anorthodontic protection device that includes: a rod of base material thathas at least one of the following compounds chosen from: a productconsisting of one or more hydrocarbon-based waxes that may also includeinorganic and/or organic fillers; an uncured (uncrosslinked) siliconehigh consistency rubber base (understood by those practiced in the artto consist of a proprietary blend of one more silicones with untreatedand/or treated silica filler); and a hydrophobic water insoluble solidmaterial that is malleable at 37° C. or lower and safe for the humanoral environment. The rod of base material has at least one dry,powdered hydrophilic polymeric substance mechanically and/orfrictionally engaged with and dispersed on one or more surfaces of therod thereby forming a finger force malleable hydrophobic base materialcomposite configured to be applied to a surface of a tooth, a surface ofan orthodontic appliance or both a surface of a tooth and a surface ofan orthodontic appliance using finger pressure within about 8 seconds orless. The surface of the tooth and/or the surface of the orthodonticdevice, because they are in the mouth, are typically wet with saliva.

Yet another aspect of the present disclosure is generally directed to anorthodontic protection device having: an extruded or otherwise shapedbase material comprising at least one of the following compounds: aproduct consisting of one or more hydrocarbon-based waxes that may alsoinclude inorganic and/or organic fillers; an uncured (uncrosslinked)silicone high consistency rubber base; and a hydrophobic water insolublesolid material that is malleable at 37° C. or lower and safe for thehuman oral environment. The rod of base material has at least one dry,powdered hydrophilic polymeric substance mechanical engaged with anddispersed on one or more surfaces of the rod thereby forming a fingerforce malleable hydrophobic base material composite configured to beapplied to a surface of a tooth, a surface of an orthodontic applianceor both a surface of a tooth and a surface of an orthodontic applianceusing finger pressure within about 8 seconds or less. Again, the surfaceof the tooth and/or the surface of the orthodontic device, because theyare in the mouth, are typically wet with saliva.

Another aspect of the present disclosure is generally directed to anorthodontic protection device that includes: an extruded base materialhaving an uncured, uncross-linked silicone high consistency rubber basewhere the extruded base material has at least one dry, powderedhydrophilic polymeric substance mechanically or frictionally engagedwith and dispersed on a surface of the extruded base material therebyforming a finger force malleable hydrophobic base material compositeconfigured to be applied to a surface of a tooth, a surface of anorthodontic appliance or both a surface of a tooth and a surface of anorthodontic appliance using finger pressure within about 8 seconds orless.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is perspective view showing three types of orthodontic protectiondevices, dental wax 10, the clear uncured (uncrosslinked) silicone highconsistency rubber base powder coated devices of the present disclosure11; and prior uncured (uncrosslinked) silicone high consistency rubberbase having PVP and glycerin dispersed throughout thereby forming areadily visible white coating material.

FIG. 2 is a perspective view of the following: an uncoated uncured(uncrosslinked) silicone high consistency rubber base that form the basematerial in strip form; an uncoated uncured (uncrosslinked) siliconehigh consistency rubber base material in strip form coated with the drypowder compositions; and the uncured (uncrosslinked) silicone highconsistency rubber base in single tooth orthodontic device coveringsizes—substantially cubic form.

FIG. 3 is a perspective view of two rollers, one feeding the uncured(uncrosslinked) silicone high consistency rubber base material and theother having a knurled or grooved or other textured surface to bothoptionally create indentations into the base material and also transportthe dry powder adhesive material into engagement with the base.

FIG. 4 is an enlarged perspective view of a system of the presentdisclosure employing a twin roller system to create the products of thepresent disclosure. In particular the dry powder feed cavity is shown inthe guide above the knurled or textured roller to feed dry powder intothe textured surface of the roller prior to it being mechanically forcedinto engagement with the uncured (uncrosslinked) silicone highconsistency rubber base material.

FIG. 5 is an enlarged perspective view of the dry powder feed cavityshown in FIG. 4, but with powder inserted therein.

FIG. 6 is an enlarged perspective view of a roller system of the presentdisclosure with the rollers aligned next to one another with the drypowder feed cavity spaced above the textured surfaced roller and thebase delivering roller and the textured roller adjacent laterally withone another.

FIG. 7 is an enlarged perspective view of a system of the presentdisclosure with the textured roller receiving the dry powder and spacedabove the uncured (uncrosslinked) silicone high consistency rubber basematerial delivering roller.

FIG. 8 is a cross-sectional view of an extrusion die opening that has apattern that would cut/form microgrooves on a single surface of the basematerial of the present disclosure.

FIG. 9A is an elevated side view showing a cutout location of a urethanerod and a coaxial, swivel bar engaging peg.

FIG. 9B is an elevated top view showing a cutout location of a urethanerod and a coaxial, swivel bar engaging peg.

FIG. 9C is a cross-sectional view taken along line C-C in FIG. 9B.

FIG. 10 is an elevated plan view of a swivel bar that holds the urethanerod holder containing a urethane rod therein and allows for adjustableor fixed amount of pressure to be applied to the adhesive and engage itto a surface of the base material.

FIG. 11 is a perspective view of the urethane rod, finger pressuresimulating force applying device.

FIG. 12 is a perspective view of the finger force malleable materialbeing extruded to include PVP receiving microgrooves on a top lengthsurface of the base material.

FIG. 13 is a perspective view of the extruded base material entering theapplication station where hydrophilic polymeric material(s) are applied.

FIG. 14 is a perspective view of the extruded and coated base materialdeparting the application station/system with the hydrophilic polymericmaterial(s) applied thereto.

FIG. 15 is a perspective view of the finger pressure applicator systemapplying pressure to the loose dry hydrophilic polymeric material(s)into frictional engagement with the base material.

FIG. 16 is a perspective view of the vacuum removal system andguillotine cutting system to make predetermined sized orthodonticprotection devices to cover one or more tooth surface and a dentalappliance or orthodontic device.

FIG. 17 is a perspective view of the cut and sized orthodonticprotection devices traveling along a conveyor belt system to be packagedfor use and delivery to the end user. Typically, the devices arepackaged in individual tamper evident containers.

FIG. 18 shows the percent transmittance of various base materials coatedwith PVP as the hydrophilic polymeric material. AO (AmericanOrthodontics) wax, GUM™ brand wax, DENTEK™ brand wax were compared alongwith Dow Corning™ SILASTIC Q7-4550 Medical Grade ETR Elastomer.

FIG. 19 is a perspective view of an overall assembly system for theproduction of the powder coated malleable hydrophobic orthodontic deviceshields of the present disclosure.

DETAILED DESCRIPTION

The present disclosure generally relates to improved hydrocarbon wax orsilicone based finger force malleable hydrophobic materials. Thematerials are sufficiently sticky towards certain hydrophilic polymericsubstances, in dry powder form, such that exposure (contact) of thesurface of the finger force malleable hydrophobic material to thepowders results in a retained coating of the powders on the hydrocarbonwax or silicone based finger force malleable hydrophobic base. Exposureof the surface or surfaces of the finger force malleable hydrophobicmaterial to the powder may be accomplished in a variety of manners andusing manual or mechanical techniques. For example, the powder may beapplied to the surface or surfaces by dragging the material through thepowder, dropping the powder onto the material either directly or withthe aid of mechanical means such as but not limited to some type ofpowder fed rotating wheel or conveyor or brush, or other mechanicalmeans such as spraying the powder onto the material via use of a simpleair-pressurized powder sprayer or an electrostatic powder sprayer. Thedry powder on the surface of the hydrocarbon wax or silicone basedfinger force malleable hydrophobic base forms a dry powder coated fingerforce malleable hydrophobic material that adheres to wet surfaces suchas saliva or water coated teeth and/or orthodontic devices. The drypowder coated base material adheres almost immediately upon fingerpressure application to the teeth. Adherence is typically achieved inless than 10 seconds, more typically less than 8 seconds and moretypically less than 5 seconds and most typically nearly immediately uponfingertip pressure application to the typical tooth or orthodonticdevice.

Additionally, the powder coated hydrocarbon wax or silicone based fingerforce malleable hydrophobic base material composite may be formed byapplying, for example by rubbing or pushing the powdered hydrophilicsubstance(s) into the surface of the malleable hydrophobic material,optionally followed by removing any loose powdered hydrophilicsubstance(s). The resulting powder coated composite yields a devicethat: (1) permanently contains a sufficient amount of hydrophilicpolymeric substance at the surface (typically only on the surface) ofthe malleable hydrophobic material such that it is rendered adhesive innearly instantaneous fashion, upon pushing on with finger pressure, toteeth and orthodontic braces that are wet with saliva; and (2) staysadhered to teeth and orthodontic braces that are wet with saliva forextended periods (for two or more hours).

Applying, which is typically done by rubbing or pushing the dry powderedhydrophilic polymeric substance into the malleable hydrophobic material,may be accomplished by a variety of mechanical means, either separatelyor in combination, and include a press, a roller, rods, a blade, all ofwhich makes contact with the surface of the malleable hydrophobicmaterial to which the powdered hydrophilic polymeric substance has beendeposited. Removing loose dry powdered hydrophilic substance that doesnot adhere to or is not impregnated into the surface of the malleablehydrophobic material may be accomplished by shaking, brushing, airpressure, or vacuum. Alternatively, upon contact of the dry powderedhydrophilic substance with one or more surfaces of the malleablehydrophobic material, no rubbing or pushing of the dry powderedhydrophilic substance may be done, and no removal of loose dry powderedhydrophilic substance may be done, and the device used as is.

Suitable malleable hydrophobic materials include, but are not limitedto: Orthodontic relief Wax (a product consisting of one or morehydrocarbon-based waxes that may also include inorganic and/or organicfillers); uncured (uncrosslinked) silicone high consistency rubber (HCR)base material, which as discussed above is a blend of one more siliconeswith untreated and/or treated silica filler, or any hydrophobic waterinsoluble solid material that is malleable at 37° C. or lower and safefor the human oral environment. The uncured (uncrosslinked) siliconehigh consistency rubber base material incorporates proprietarysilicones, proprietary amounts of silicone or silica filler andproprietary silica filter material characteristics. In the industry,this information is kept a trade secret. An “uncured (uncrosslinked)silicone high consistency rubber base material” is a known category ofsilicone materials to chemists familiar with silicone polymers and/orsilicone materials. Regarding the uncured (uncrosslinked) silicone HCRbase material, many companies market uncured (uncrosslinked) siliconehigh consistency rubber base that could be used for inventions of thepresent disclosure. These include but are not limited to: WackerELASTOSIL® R PLUS 4000/50; Wacker ELASTOSIL® R 401/50 S; WackerELASTOSIL® R PLUS 4305/70; Wacker ELASTOSIL® R PLUS 4305/60; WackerELASTOSIL® R plus 4305/80; Wacker ELASTOSIL® R 401/80 S; NUSIL™MED-2174; NUSIL™ MED-4174; Dow Corning Silastic Q7-4535 Medical GradeETR Elastomer; Dow Corning Silastic Q7-4550 Medical Grade ETR Elastomer;Dow Corning Silastic Q7-4565 Medical Grade ETR Elastomer, and HoshineHS-1552PT High Transparency Extrusion Silicone Rubber. The malleablehydrophobic materially may be extruded or otherwise formed by shapingthe material. Other ways of forming the base, malleable, hydrophobicmaterial into a shaped base include, but are not limited to, using amechanical flat press or a roller press to produce flat sheets that arethen coated with the dry powdered hydrophilic polymeric substance(s) andcut into pieces, or pressing the base, malleable, hydrophobic materialinto a mold, then opening the mold and removing the shaped pieces, whichwould thereafter be coated with the dry powdered hydrophilic polymericsubstance(s) and optionally cut into smaller pieces or shaped, or thepowdered hydrophilic polymeric substance(s) could be directly deposited(dusted) onto the mold surfaces as a mold release agent, ending upincorporated onto the surface of the molded piece.

Suitable dry powdered hydrophilic polymeric substances are those thatcan serve as moisture activated pressure sensitive adhesives and absorbwater and are substantially soluble in water. These include, but are notlimited to, any material from a list comprising: polyvinylpyrrolidones(PVPs), polyoxazolines, polyethylene glycols, starches, polyacrylicacids, carbomers, polyvinyl alcohols, polyvinyl acetates, cellulosederivatives, polysaccharides (such as xanthan, pectin, guar gum,starches, cellulose ethers, chitosan derivatives), polyacrylamides,N-vinyl caprolactam polymers, and copolymers of methyl vinyl ether andmaleic anhydride (PVM/MA), and other water-soluble polymeric adhesivesor blends of any of the above or other water-soluble polymericadhesives. The water-soluble polymeric adhesive(s) are safe for use inthe buccal cavity of a human. One particular polyvinylpyrrolidone thatmay be used is PLASDONE® K-29/32 polymer, which is a stable,water-soluble polyvinylpyrrolidone that meets U.S., European andJapanese pharmacopoeia specifications for povidone.

Additionally, one or more dry powdered flavor substances may be added tothe hydrophilic polymeric substances mentioned above to yield a flavorsensation to those using the devices upon application to teeth andorthodontic braces that are wet with saliva. In addition, water soluble(to any extent) compounds that produce a variety of benefits to toothenamel and oral health in general can be included and mixed with the drypowdered hydrophilic polymeric substance and be delivered in aneffective amount and manner over a treatment effective period of time.One or more such compounds may be used. Some of the treatment or benefitinducing compounds that can be included into in a mixture with the drypowdered hydrophilic substance(s) to form the mixture that is applied toa surface of the malleable hydrophobic material include, but are notlimited to, the following: sodium fluoride, stannous fluoride,acidulated phosphate fluoride, sodium monofluorophosphate, calciumsulfate, calcium acetate, calcium lactate (with or without addition ofxylitol, the combination remineralizes tooth enamel), calcium phosphate,amorphous calcium phosphate complexed with casein phosphopeptides,tricalcium phosphate that has been mechanochemical ball milled withfumaric acid, calcium sulfate, sodium phosphate, potassium phosphate,dipotassium phosphate, and others. Calcium salts and phosphate saltswith or without fluoride or carbonate salts may be used. Materials suchas calcium chloride, sodium phosphate and sodium fluoride may be placedinto non-aqueous mediums and, when they come into contact with saliva,for example, are then re-precipitated as amorphous calcium phosphate,amorphous calcium phosphate fluoride, amorphous calcium carbonatephosphate or amorphous calcium carbonate phosphate fluoride forremineralization of the teeth. The remineralization is further aided bythe extended time the composite with the treatment material/componentscontained therein are applied to the teeth in the context of the presentdisclosure and their positioning directly around, adjacent and over thebraces, which are particular locations where demineralization oftenoccurs when braces are worn. The area around the orthodontic device isparticularly treated. In addition, any of the above combination ofbenefit inducing compounds that lead to precipitate formation in exposeddentinal tubules may be employed for treatment of dentinhypersensitivity.

Additionally, one or more colorants (pigments) that are safe for use inthe buccal cavity may be added to the base material to achieve a fingerforce malleable hydrophobic material of any color. Examples of colorantsinclude but are not limited to Silcogum Blue 243, Silcogum Red 324, andSilcogum Yellow 129, marketed by PolyOne Corporation.

Conceivably, the present dry powdered hydrophilic polymeric substance(s)alone or, as discussed above, in combination with one or more of any ofthe above mentioned materials, typically the water soluble materials maybe mixed or blended together into a mixture/blend to be applied to asurface of one or a plurality of surfaces of the malleable hydrophobicmaterials. The dry powdered hydrophilic polymeric substance(s) adheresthe overall device to a tooth and facilitates delivery of the treatmentor tooth benefit material to a surface of one or more of these toothbeneficial materials onto the teeth surfaces or an individual toothsurface that does or does not have an orthodontic device attachedthereto and used to apply a delivery method to a tooth for delivery ofone or more treatment compositions or compound types whether or not anorthodontic device or devices are present. As with the dry powderedhydrophilic polymeric substance, typically a PVP or mixture of PVPs, dueto the water soluble nature of the materials, they hydrate when appliedto the surface of the teeth and do not prevent the orthodontic devicesof the present invention from becoming at least substantially clear, butmore typically clear to the naked eye. Regardless of whether or notthese other water soluble components are used, the dry powderedhydrophilic polymeric substance(s) of the present disclosure become atleast substantially clear or clear and also typically colorless unless acolorant is added to either the dry powdered hydrophilic polymericsubstance including mixture or on the surface of the base material uponhydration by moisture in the air or in the buccal cavity such as whenapplied to the teeth, tooth or both one or more tooth and one or moreorthodontic devices on the tooth. The hydrophilic polymeric substancebecomes essentially clear or completely clear within about 10 seconds orless, more typically about 5 seconds or less, 2 seconds or less or evenwithin one second or less after the application of the hydrophilicpolymer coated malleable hydrophobic materials to a surface of one ormore teeth and/or a surface of an orthodontic device.

Before the subject matter of the present disclosure is describedfurther, it is to be understood that the disclosure is not limited tothe particular embodiments of the disclosure described below, asvariations of the particular embodiments may be made and still fallwithin the scope of the appended claims. It is also to be understoodthat the terminology employed is for the purpose of describingparticular embodiments, and is not intended to be limiting, instead, thescope of the present disclosure will be established by the appendedclaims.

Example I: Dow Corning SILASTIC® Q7-4550 High Consistency Rubber Basewas extruded through a 6 mm×3 mm stainless steel die to produce mostlyclear, colorless rectangular rods (See FIG. 2). These rods were adherentto dry surfaces but totally non-adherent to wet (with water) surfaces.Next, an extruded rod was dragged through a dish containing AshlandPLASDONE® K29/32 polyvinylpyrrolidone (PVP) fine white dry powder,coating the rod. Next, excess powder was removed from the surfaces ofthe rod by brushing it off either with a nylon brush or simply with afinger, resulting in an opaque surface appearance due to the powdercoating that adhered to the rod. As shown in FIG. 2, pieces of 6 mmlength were cut from the rod, resulting in 3 mm×6 mm×6 mm pieces inwhich the two 6 mm×6 mm faces and two of the 6 mm×3 mm faces were coatedwith powdered PVP. When these pieces were applied (pushed on withpressure from a dry finger) to wet teeth in such a manner that one ofthe coated surfaces made contact with the wet teeth, the piece adheredinstantly to the wet tooth and stayed on for three to eight hours,during which time beverages were consumed. Additionally, the piece incontact with the dry finger did not adhere to the dry finger.Additionally, the same adhesive behavior was observed if excess PVP wasnot brushed off before application to the wet tooth.

Example II: Dow Corning SILASTIC® Q7-4550 High Consistency Rubber Basewas extruded through a 6 mm×3 mm stainless steel die to produce mostlyclear, colorless rectangular rods. These rods were adherent to drysurfaces but totally non-adherent to wet (with water) surfaces.

Next, the top surface of a rod was textured by rolling a rotary wirewheel over the surface of the rod, producing a multitude of smalldepressions along the surface.

Next, excess Ashland PLASDONE® K29/32 polyvinylpyrrolidone (PVP) drypowder was deposited onto the textured surface of the rod, the PVP wasrubbed into the surface with gentle pressure using a dry finger or theflat surface of a stainless steel spatula or a smooth or textured metalroller, and then excess powder was removed from the surfaces of the rodby brushing it off either with a nylon brush or simply with a finger,resulting in an opaque surface appearance due to the powder coating thatadhered to the rod and some white spots due to PVP-filled depressions onthe textured surface.

Pieces of 6 mm length were cut from the surface coated rod, resulting in3 mm×6 mm×6 mm pieces in which the two 6 mm×6 mm faces and two of the 6mm×3 mm faces were coated with powdered PVP. When these pieces wereapplied (pushed on with pressure from a dry finger) to wet teeth in sucha manner that the coated surfaces made contact with the wet teeth, thepiece adhered instantly to the wet tooth and stayed on for three toeight hours, during which time beverages were consumed. Additionally,the piece in contact with the dry finger did not adhere to the dryfinger. Additionally, when applied to a wet (with saliva) orthodonticbracket in the mouth, the piece adhered instantly to the wettooth/bracket and stayed on for nine hours, during which time beveragesand foods were consumed. Additionally, the same adhesive behavior wasobserved if excess PVP was not brushed off before application to the wettooth. Texturing the surface in any way is completely optional as thedevice works well if the PVP is pressed into the non-textured surface aswell.

Example III: A circular-cross-section rod of American Orthodontic ReliefWax was torn from a package containing five fused rods of wax. The waxrod was adherent to dry surfaces but totally non-adherent to wet (withwater) surfaces. Next, Ashland PLASDONE® K29/32 polyvinylpyrrolidone(PVP) fine white dry powder was rubbed into the wax rod with a dryfinger or with the flat surface of a stainless steel spatula, coatingthe rod. Next, excess powder was removed from the surfaces of the rod bybrushing it off either with a nylon brush or simply with a finger,resulting in an opaque surface appearance due to the powder coating thatadhered to the rod. Pieces of 6 mm length were cut from the rod. Whenthese pieces were applied (pushed on with pressure from a dry finger) towet teeth in such a manner that one a coated surface made contact withthe wet teeth, the piece adhered instantly to the wet tooth and stayedon for three to eight hours, during which time beverages were consumed.Additionally, the piece in contact with the dry finger did not adhere tothe dry finger. Additionally, the same adhesive behavior was observed ifexcess PVP was not brushed off before application to the wet tooth.

Example IV: Dow Corning SILASTIC® Q7-4550 High Consistency Rubber Basewas extruded through a 6 mm×3 mm stainless steel die to produce mostlyclear, colorless rectangular rods. These rods were adherent to drysurfaces but totally non-adherent to wet (with water) surfaces. Next, anextruded rod was dragged through a dish containing Lubrizol CARBOPOL®940 Polymer (polyacrylic acid polymer) fine white dry powder, coatingthe rod. Next, excess powder was removed from the surfaces of the rod bybrushing it off either with a nylon brush or simply with a finger,resulting in an opaque surface appearance due to the powder coating thatadhered to the rod. Pieces of 6 mm length were cut from the rod,resulting in 3 mm×6 mm×6 mm pieces in which the two 6 mm×6 mm faces andtwo of the 6 mm×3 mm faces were coated with powdered CARBOPOL® 940. Whenthese pieces were applied (pushed on with pressure from a dry finger) towet teeth in such a manner that one of the coated surfaces made contactwith the wet teeth, the piece adhered instantly to the wet tooth andstayed on for three to eight hours, during which time beverages wereconsumed. Additionally, the piece in contact with the dry finger did notadhere to the dry finger. Additionally, the same adhesive behavior wasobserved if excess CARBOPOL® 940 was not brushed off before applicationto the wet tooth.

Example V: A circular rod of American Orthodontic Relief Wax was tornfrom a package containing 5 fused rods of wax. The wax rod was adherentto dry surfaces but totally non-adherent to wet (with water) surfaces.Next, Lubrizol CARBOPOL® 940 Polymer (polyacrylic acid polymer) finewhite dry powder was rubbed into the wax rod with a dry finger or withthe flat surface of a stainless steel spatula or with a smooth ortextured metal roller, coating the rod. Next, excess powder was removedfrom the surfaces of the rod by brushing it off either with a nylonbrush or simply with a finger, resulting in an opaque surface appearancedue to the powder coating that adhered to the rod. Pieces of 6 mm lengthwere cut from the rod. When these pieces were applied (pushed on withpressure from a dry finger) to wet teeth in such a manner that one acoated surface made contact with the wet teeth, the piece adheredinstantly to the wet tooth and stayed on for three to eight hours,during which time beverages were consumed. Additionally, the piece incontact with the dry finger did not adhere to the dry finger.Additionally, the same adhesive behavior was observed if excessCARBOPOL® 940 was not brushed off before application to the wet tooth.

As shown in FIG. 3, the method of applying the dry powder adhesivematerial of the present disclosure may utilize a knurled or otherwisetextured roller 40 and a second roller 42 that has a groove/channel 44that receives hydrocarbon wax or silicone based finger force malleablehydrophobic base material 30. Notably, while it may do so, the knurledor otherwise textured roller does not typically apply a texture to theextruded base material 30. The textured surface is obtained using a dieduring the extrusion process (see FIG. 8 and FIG. 12). Instead, theknurled or textured roller utilized the cavities in the roller to holdthe dry powder adhesive material before it is applied. If atexturization is made to the base material, this texturization is doneas the base material is extruded by extruding the base material throughan extrusion die as shown in FIG. 8. The extrusion die has an about 6mm×about 3 mm shape. The pattern on one surface, the surface to receivethe dry powder adhesive, is a series of microgrooves producingprojections (A) extending from a side of the die and having a maximumdepth of about 0.02 inches, but conceivably the depth could be fromabout 0.4 to about 0.01 inches. The main purpose of the grooves would beto create substantially V-shaped channels within which the dry adhesivematerial may be placed as the extruded rod passes through the overallsystem and the knurled or otherwise textured roller 40 and the secondroller 42. Conceivably, the use of a textured roller 40 is unnecessarywhen the micro-grooved extruded rod of base material is employed, buttypically both are utilized to ensure the dry powder adhesive isdelivered into the microgrooves. As shown in at least FIG. 3, the tworollers 40, 42 are proximate one another such that the dry powderadhesive material in the textured surface on one side of the basematerial 30 (the optionally micro-grooved side) is delivered intoengagement with the base 30 within the created textured surface 46 or onthe flat unmicrogrooved surface of the extruded rod of base material 30.In FIG. 3 and other figures of this application, the textured surface,which would typically have linear (typically V-shaped) groovesconsistent with the die shown in FIG. 8, is shown with the adhesivepowder applied in the knurled pattern on the base material. However, thegrooves typically would be present. This creates a continuous productionprocess.

FIG. 4 shows the process for forming the composite material of base 30and powder engaged to a surface of the composite, but shows the systemwithout the powder inserted into the dry powder feed cavity 48 in thepowder guide bracket 50, which is spaced above the textured or knurledroller 40 such that powder is delivered to the grooves of the texturedor knurled portion 46 of the roller 40. The roller 42 may be spacedbelow or adjacent or otherwise in a force receiving engagement with thetextured roller 40. FIG. 5 shows the system with the dry powderparticles 52 generally shown filled into the dry powder feed cavity 48.FIG. 6 shows the system with a third roller 54 on the feed side of thesystem to feed the base material 30 into the knurled or textured roller40. The base material is shown smooth on this side of the system. FIG. 7shows the other side of the system after the powder is applied andtexturizing done to the base material to form the dry powder coatedcomposite orthodontic protection device material 56 of the presentdisclosure.

FIG. 8 shows a cross-sectional view of the die of the extrusion of thepresent disclosure. The die forms a plurality, typically about 5 ormore, of grooves on a length of the rectangular cross-section. The dieshown in FIG. 8 is one version of an extrusion die opening that isroughly 6 mm (B)×3 mm (D) that has a pattern that would be cut into itusing EDM (Electric Discharge Machining) wire cutting. The die placesmicrogrooves into the surface of the silicone rod. The microgroovesreceive the hydrophilic polymeric substance(s) such as PVP in powderform when it is deposited onto it. This does two things: First, themicrogrooves make the surface that has been powdered more obvious to theuser. Second, the grooves carry additional amounts of hydrophilicpolymeric substance(s) such as PVP. While not necessary for adhesion,the added amounts of the hydrophilic polymeric substance(s) facilitategreater adhesion forces to the surface of the tooth/teeth and/or asurface of a dental appliance or orthodontic device. FIG. 8 shows tengrooves, however, fewer or more grooves may be employed. Typically tenor fewer, more typically five grooves or fewer are used.

The dry powdered hydrophilic polymeric material, such as PVP, when inthe open and exposed to ambient humidity, goes from a non-tacky drywhite powder to eventually (within 1 month or less depending on ambienthumidity and other factors) a clear and colorless solid (almost likeglass) that remains non-tacky during this time of hydration andincreasing in mass by approximately 20%. Both the PVP powder—if appliedas a powder—and the glass-like solid, when in that form, adhere to wetteeth, orthodontic device or both or a plurality of one or more of each.

An artificial finger pressure application device is typically usedduring production of the overall orthodontic protection device istypically used to apply a finger pressure amount of from 0.2 psi toabout 2 psi and force the dry powdered hydrophilic polymeric material(s)to mechanically adhere to at least one (typically one) surface of theextruded base material. The pressure could be slightly more thanfingertip pressure of up to about 4 psi as well. The construction of theartificial finger pressure application device 70 is shown in FIGS. 9-11.The device 70 engages the swivel bar 80 using the mountingpeg/projection 79, which is engaged with a receiving aperture 81 in theswivel bar 80. The device 70 has a housing 72 that receives the softurethane artificial finger 74. The housing has an outwardly extendingpeg 76 that extends along the longitudinal axis of the device 70 and isremovably and rotatably engaged, typically by hand and without the useof tools, with a recess 82 in the swivel bar 80. The device 70 isengaged in the processing line to press the PVP into the extrudedsilicone rod after the knurled wheel deposits PVP.

FIG. 12 shows a finger force malleable material being extruded to formPVP receiving microgrooves 90 on a top length surface 92 of the basematerial 20. Once extruded, the base material 20 proceeds to go under aguide roller 94 (See FIG. 13) and into the larger extruded base materialreceiving roller 42. The grooved base material is fed into thegroove(s)/channel(s) 44. As shown in FIGS. 13-14, the base materialproceeds such that the PVP and/or other hydrophilic polymericmaterial(s) is applied, typically by gravity at this stage, onto the topsurface of the base material from the knurled portion(s) 46. The PVPand/or other hydrophilic polymeric material(s) are delivered from afunnel or other container spaced above the knurled portion(s) such thatthe PVP and/or other hydrophilic polymeric material(s) are delivered bygravity through the downspout of the funnel and into the knurledportion(s) which then deliver the PVP and/or other hydrophilic polymericmaterial(s) to the base material.

As shown in FIG. 15, the PVP and/or other hydrophilic polymericmaterial(s) coated base material then is guided under the artificialfinger pressure application device such that essentially a pressure inthe amount of finger pressure (about 0.2 to about 2 psi or less). FIG.16 shows the coated base material proceeding under a rod 96 and betweentwo guide posts 98. The rod 96 has a vacuum that removes any loose andnot frictionally engaged hydrophilic polymeric material(s) from asurface of the base material. Typically, hydrophilic polymericmaterial(s), such as PVP, are only applied to one surface to make thatsurface the user evident surface to be applied to the surface of thetooth/teeth/dental device(s). The vacuum helps remove excess hydrophilicpolymeric material(s) from other surfaces the material may be looselyconnected to. Once applied by the end user, as discussed above the basematerial and the hydrophilic polymeric material(s) become essentiallyclear or visibly clear to the naked eye. FIG. 17 shows the cut and sizedorthodontic protection devices traveling along a conveyor belt system tobe packaged for use and delivery to the end user. Typically, the devicesare thereafter packaged in individual tamper evident containers.

FIG. 18 shows the percent transmittance of various base materials coatedwith PVP as the hydrophilic polymeric material. AO (AmericanOrthodontics) wax, GUM™ brand wax, DENTEK™ brand wax were compared alongwith Dow Corning™ SILASTIC Q7-4550 Medical Grade ETR Elastomer.

FIG. 16 also shows the guillotine cutting system 100 that is used to cutthe orthodontic protection devices into a predetermined size for eachorthodontic protection device. Typically they are in the form of a “dot”200 sized to cover one tooth surface and a dental appliance ororthodontic device; however, the devices can be sized to cover aplurality of teeth and orthodontic devices in a manner similar to amouth guard would protect multiple teeth and the buccal liner facing theteeth and orthodontic device(s). The system typically produces 2 “dots”per second (one “dot” per second from each of two rods), but the systemcould run at a rate as fast as 2 “dots” per extruded rod per secondutilized instead of one or conceivably at slower speeds as well. Thesystem may also run at one “dot” per 0.66 seconds per extruded rod. InFIG. 19, an acrylic clear tube 102 holding the PVP powder (thehydrophilic polymeric material(s)) is shown. Inside and also attached tothe acrylic tube 102 will be vibrators (not shown) which actuate,typically at programmable intervals, to make sure the PVP powder (thehydrophilic polymeric material(s)) shakes down into the applicator. Thepaper fill funnel 104 will be replaced with a real type of funnel. Thelarge white grooved Teflon® 42 roller that holds the extruded rod as itreceives PVP powder (the hydrophilic polymeric material(s)) applied(typically dropped) onto it also has an adjustable spring attached tothe urethane press bar/device 70, and a white Teflon® scraper 106 belowto help remove the extruded rod from the groove in the Teflon roller 42.You can also see two tubes hooked to a vacuum cleaner. The knurled steelroller that fills with PVP powder (the hydrophilic polymericmaterial(s)) and transfers it to the extruded rod can be of variousdepths to the knurls, which in turn controls how much PVP powder (thehydrophilic polymeric material(s)) gets dumped onto the base material(extruded rods). It is part of the black roller, black because it hasbeen anodized.

A KEYENCE® vision system or similar vision system is typically used inconnection with the present systems to ensure that a minimum level ofthe hydrophobic water insoluble solid material (typically PVP alone orin combination with one or more of the other substances discussed above)is applied by measuring how white the material is leaving themanufacturing device. If there is not sufficient PVP or other powdermaterial applied to the surface, the vision system will identify thisstate and notify the user of the production device(s) to stop the systemand/or add more PVP or other hydrophobic water insoluble solidmaterial(s) to the applicator or the funnel delivery system/hopper sothat the hydrophobic water insoluble solid material(s) are available inadequate amounts.

What is claimed is:
 1. An orthodontic protection device comprising: arod of base material comprising at least one of the following compoundschosen from the group consisting of: a product consisting of one or morehydrocarbon-based waxes that may also include inorganic fillers and/ororganic fillers; an uncured, uncross-linked silicone high consistencyrubber base; and a hydrophobic water insoluble solid material that ismalleable at 37° C. or lower and safe for a human oral environment; andwherein the rod of base material has at least one dry, powderedhydrophilic polymeric substance mechanically or frictionally engagedwith and dispersed on one or more surface of the rod of base materialthereby forming a finger force malleable hydrophobic base materialcomposite configured to be applied to a surface of a tooth, a surface ofan orthodontic appliance or both a surface of a tooth and a surface ofan orthodontic appliance using finger pressure within about 8 seconds orless.
 2. The orthodontic protection device of claim 1, wherein the rodof base material is an extruded rod comprising the uncured,uncross-linked silicone high consistency rubber base and the rod of basematerial is substantially cuboidal shaped.
 3. The orthodontic protectiondevice of claim 2, wherein the dry, powdered hydrophilic polymericsubstance is chosen from the group consisting of: apolyvinylpyrrolidone, a polyoxazoline, a polyethylene glycol, a starch,a polyacrylic acid, a carbomer, a polyvinyl alcohol, a polyvinylacetate, a cellulose derivative, a polysaccharide, a polyacrylamide, aN-vinyl caprolactam polymer, a copolymer of methyl vinyl ether andmaleic anhydride (PVM/MA), and blends of any of the above.
 4. Theorthodontic protection device of claim 3, wherein the polysaccharide isa xanthan gum, a pectin, a guar gum, a starch, a cellulose ether, or achitosan derivative.
 5. The orthodontic protection device of claim 1,wherein the at least one dry, powdered hydrophilic polymeric substancecomprises one or more water-soluble polymeric adhesive.
 6. Theorthodontic protection device of claim 1, wherein the rod of basematerial has a textured surface and the rod of base material having atleast one dry, powdered hydrophilic polymeric substance mechanicalengaged with and dispersed on the textured surface of the rod of basematerial.
 7. The orthodontic protection device of claim 6, wherein therod of base material has a dry, powdered hydrophilic polymeric substanceon one surface thereof.
 8. The orthodontic protection device of claim 1,wherein the at least one dry, powdered hydrophilic polymeric substanceis mechanical engaged to only one surface of the rod of base material.9. The orthodontic protection device of claim 1, wherein the device isat least substantially clear when applied to the surface of the tooth,the surface of the orthodontic device or the surface of the tooth andthe surface of the orthodontic device in a buccal cavity.
 10. Theorthodontic protection device of claim 3, wherein the device is at leastsubstantially clear when applied to the surface of the tooth, thesurface of the orthodontic device or the surface of the tooth and thesurface of the orthodontic device in a buccal cavity.
 11. Theorthodontic protection device of claim 10, wherein the devicepermanently contains a sufficient amount of the dry, powderedhydrophilic polymeric substance at the surface of the finger forcemalleable hydrophobic base material composite such that the orthodonticprotection device is rendered adhesive in a substantially instantaneousfashion, upon pushing on with finger pressure to a tooth surface that iswet, a surface of an orthodontic brace that is wet, or a surface of atooth and a surface of an orthodontic brace that are wet.
 12. Theorthodontic protection device of claim 11, wherein the orthodonticprotection device, once applied to the tooth surface that is wet, thesurface of the orthodontic brace that is wet, or the surface of thetooth and the surface of the orthodontic brace that are wet, staysadhered to teeth and orthodontic braces that are wet with saliva for atleast eight hours unless removed by an outside force.
 13. An orthodonticprotection device comprising: an extruded base material comprising atleast one of the following compounds chosen from the group consistingof: a product consisting of one or more hydrocarbon-based waxes that mayalso include inorganic or inorganic fillers; an uncured, uncrosslinkedsilicone high consistency rubber base; and a hydrophobic water insolublesolid material that is malleable at 37° C. or lower and safe for a humanoral environment; and wherein the extruded base material has at leastone dry, powdered hydrophilic polymeric substance mechanically orfrictionally engaged with and dispersed on a surface of the extrudedbase material thereby forming a finger force malleable hydrophobic basematerial composite configured to be applied to a surface of a tooth, asurface of an orthodontic appliance or both a surface of a tooth and asurface of an orthodontic appliance using finger pressure within about 8seconds or less.
 14. The orthodontic protection device of claim 13,wherein the orthodontic protection device, once applied to a toothsurface that is wet, a surface of an orthodontic brace that is wet, or asurface of a tooth and a surface of an orthodontic brace that are wet,stays adhered to teeth and orthodontic braces that are wet with salivafor at least eight hours unless removed by an outside force.
 15. Theorthodontic protection device of claim 14, wherein a sufficient amountof the dry, powdered hydrophilic polymeric substance at the surface ofthe finger force malleable hydrophobic base material composite such thatthe orthodontic protection device is rendered adhesive in asubstantially instantaneous fashion, upon pushing on with fingerpressure to the tooth surface that is wet, the surface of theorthodontic brace that is wet, or the surface of the tooth and thesurface of the orthodontic brace that are wet.
 16. The orthodonticprotection device of claim 13, wherein the at least one dry, powderedhydrophilic polymeric substance is mechanically engaged with and atleast substantially uniformly dispersed on at least 85% of the surfaceof the extruded base material that engages the surface of the tooth, thesurface of the orthodontic appliance or both the surface of the toothand the surface of the orthodontic appliance.
 17. The orthodonticprotection device of claim 13, wherein the at least one dry, powderedhydrophilic polymeric substance is dispersed over all of the surface ofthe extruded base material that engages the surface of the tooth, thesurface of the orthodontic appliance or both the surface of the toothand the surface of the orthodontic appliance.
 18. The orthodonticprotection device of claim 17, wherein the orthodontic protection deviceis at least substantially clear when applied to a tooth surface of atooth, a surface of an orthodontic device or the surface of a tooth andthe surface of an orthodontic device in a buccal cavity the devicepermanently contains a sufficient amount of the dry, powderedhydrophilic polymeric substance at the surface of the finger forcemalleable hydrophobic base material composite such that the orthodonticprotection device is rendered adhesive in a substantially instantaneousfashion, upon pushing on with finger pressure to the tooth surface thatis wet, the surface of the orthodontic device that is wet, or thesurface of the tooth and the surface of the orthodontic device that iswet.
 19. An orthodontic protection device comprising: an extruded basematerial comprises an uncured, uncross-linked silicone high consistencyrubber base and wherein the extruded base material has at least one dry,powdered hydrophilic polymeric substance mechanically or frictionallyengaged with and dispersed on a surface of the extruded base materialthereby forming a finger force malleable hydrophobic base materialcomposite configured to be applied to a surface of a tooth, a surface ofan orthodontic appliance or both a surface of a tooth and a surface ofan orthodontic appliance using finger pressure within about 8 seconds orless.
 20. The orthodontic device of claim 19, wherein the orthodonticprotection device, once applied to a tooth surface that is wet, thesurface of the orthodontic appliance that is wet, or the surface of thetooth and the surface of the orthodontic appliance that are wet, staysadhered to teeth and orthodontic braces that are wet with saliva for atleast eight hours unless removed by an outside force.